Singapore legislation
Regulation 36
Regulation 36
Duty of licensed manufacturer
Without prejudice to any other provision in this Part, a holder of a manufacturer’s licence for a therapeutic product —
must ensure, and maintain objective evidence to establish, that the manufacture of the therapeutic product complies with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products;
must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities as are necessary for carrying out, in accordance with the holder’s licence, such stages of the manufacture of the therapeutic product as are undertaken by the holder;
must not carry out any stages of manufacture of the therapeutic product in any premises not specified in the holder’s licence;
must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control;
must only use the premises specified in the holder’s licence, or such other premises as may be approved from time to time by the Authority, for handling or storing the therapeutic product;
must carry out, or arrange for a testing laboratory as specified in the licence to carry out, tests on the strength, quality and purity of the therapeutic product to ensure that the standards of the therapeutic product comply with any applicable standard set by the Authority for the therapeutic product;
must conduct all manufacturing operations in such a way as to ensure that the therapeutic product is of the correct identity and conforms with the applicable standards of strength, quality and purity; and
must ensure that any tests for determining conformity with the applicable standards and specifications applying to the therapeutic product are, unless otherwise provided in the licence, applied to samples taken after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the Authority.